Prescription drug · ANDA
Paricalcitol NDC 70121-1033
Paricalcitol 2 ug/mL · Injection · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1033-5 | 70121103305 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1033-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1033-1)Marketed from Mar 9, 2017 | |
| 70121-1033-7 | 70121103307 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1033-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1033-1)Marketed from Mar 9, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Paricalcitol
- Generic name (nonproprietary)
- paricalcitol
- Active ingredients
- Paricalcitol — 2 ug/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206699
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 70121-1033_26de8aad-c6ec-4bac-ae94-5772a69b79aeSPL ID 26de8aad-c6ec-4bac-ae94-5772a69b79aeSPL set ID 8e0b016c-4bda-487e-b525-63abfb772761RxCUI 200321, 1736919, 1736931, 1807896UNII 6702D36OG5
- Pharmacologic class
- Vitamin D Analog; Vitamin D2 Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470121103305followed by a unit qualifier and the quantityPackage 70121-1033-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. Paricalcitol injection is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70121-1033
- What is NDC 70121-1033?
- 70121-1033 is the product NDC for Paricalcitol, Paricalcitol 2 ug/mL injection, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paricalcitol.
- What is the active ingredient?
- Paricalcitol.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paricalcitol?
- 34 other product NDCs are listed under this name. See all Paricalcitol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paricalcitol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paricalcitol | Paricalcitol 5 ug/mL | InjectionIntravenous | Eugia US LLC | 55150-213 | 55150-0213-01 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Eugia US LLC | 55150-214 | 55150-0214-02 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Eugia US LLC | 55150-215 | 55150-0215-02 |
| Paricalcitol | Paricalcitol 2 ug/mL | InjectionIntravenous | Eugia US LLC | 55150-212 | 55150-0212-01 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1035 | 70121-1035-0570121-1035-07 |
| Paricalcitol | Paricalcitol 5 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1034 | 70121-1034-0570121-1034-07 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1036 | 70121-1036-0570121-1036-07 |
| Paricalcitol | Paricalcitol 1 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-687 | 49483-0687-03 |
| Paricalcitol | Paricalcitol 4 ug/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-689 | 49483-0689-03 |
| Paricalcitol | Paricalcitol 2 ug/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-014 | 25000-0014-0325000-0014-49 |
Other NDCs under ANDA 206699
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1035 |
| Paricalcitol | Paricalcitol 5 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1034 |
| Paricalcitol | Paricalcitol 10 ug/2mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1036 |